Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic
Overview
- Phase
- Phase 2
- Intervention
- Dasatinib
- Conditions
- Metastatic Breast Cancer
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 120
- Locations
- 23
- Primary Endpoint
- Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to find out what effect the combination of letrozole (brand name: Femara) and dasatinib (brand name: Sprycel) has on metastatic breast cancer compared to letrozole alone
Investigators
Eligibility Criteria
Inclusion Criteria
- •Has histologic or cytologic diagnosis of breast cancer; evidence of unresectable locally recurrent or metastatic disease
- •Has measurable or evaluable-only disease
- •Is female, ≥18 yrs of age, post menopausal or surgically sterile
- •HER2 negative, HR+, ER+ and/or PgR+ breast cancer
- •0-1 prior chemotherapy regimen for metastatic disease.
- •Prior adjuvant or neoadjuvant chemotherapy completed at least 1 month prior
- •Prior tamoxifen therapy is allowed
- •No AI therapy for \>1 year without recurrence
Exclusion Criteria
- •Pregnant or breast feeding
- •Prior hormonal therapy for metastatic or locally recurrent disease
- •\>1 chemotherapy regimen for metastatic disease
- •Pleural or pericardial effusion
- •Serious cardiac condition
Arms & Interventions
A1
Intervention: Dasatinib
A1
Intervention: Letrozole
A2
Intervention: Letrozole
Outcomes
Primary Outcomes
Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population
Time Frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
CBR=participants with complete response (CR) + participants with partial response (PR) + participants with stable disease (SD) for a length of time greater than, equal to 6 months. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination,radiological assessment, and bone scans (if applicable) were used to assess outcome.
Secondary Outcomes
- Percentage of Participants Best Overall Response After Change From Letrozole to Letrozole Plus Dasatinib(First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years))
- Percentage of Participants With PFS At 6 Months and At 12 Months - ITT Population(At 6 months and at 12 months)
- Median Time to Treatment Failure (TTF) - ITT Population(First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years))
- Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population(Day 1 to Study Completion (approximately 6 years))
- Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression(First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years))
- Number of Participants With Adverse Events (AEs) Leading to Discontinuation, Serious Adverse Events (SAEs), and Deaths(First dose of study drug to last dose plus 30 days, up to study completion (approximately 6 years))